First in Human Phase 1 Dose Escalation and Expansion Clinical Trial to Evaluate the Safety, Pharmacokinetics and Antitumor Activity of Intravenous AROG4-01 in Patients With Advanced Solid Tumors

The goal of this clinical trial is to learn if drug AROG4-01 is safe in patients with solid tumors who have no available treatment alternative. Different doses will be tested in order to identify the most suitable one. Once it is identiffied, up to 20 patients will be treated with that dose, to check if thye get clinical benefit.
Participants will: receive intravenous administrations of ARG4-01 twice weekly, and visit the clinic twice every week for checkups and tests.

开始日期2025-01-01

申办/合作机构

Applied Research Using Omic Sciences SL

100 项与 NAX-035 相关的临床结果

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100 项与 NAX-035 相关的转化医学

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100 项与 NAX-035 相关的专利（医药）

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项与 NAX-035 相关的文献（医药）

2013-11-01·BioFactors3区 · 生物学

Antitumor effect of novel berberine derivatives in breast cancer cells

3区 · 生物学

Article

作者: Lombardi, Paolo ; Arcamone, Andrea G. ; Provinciali, Mauro ; Pierpaoli, Elisa ; Buzzetti, Franco ; Salvatore, Carmela

AbstractBreast cancer is the most common malignancy and the most common cause of cancer death in elderly women. Chemoprevention with dietary compounds and their synthetic analogs has emerged as an attractive strategy to prevent carcinogenic progression to invasive cancer. In this study, we investigated the efficacy of some new synthetic derivatives of berberine, a phytochemical isolated from Barberry and other plants, to induce growth arrest of HER‐2/neu overexpressing SK‐BR‐3 breast cancer cells. Supplementation with berberine or with the synthetic derivatives NAX012, NAX013, NAX014, and NAX035 exerted a dose‐ and time‐dependent inhibition of SK‐BR‐3 cell viability, with a greater effectiveness of NAX012 and NAX014 compounds with respect to berberine. This cytotoxic effect was related to an increased number of apoptotic cells that reached 71.6% and 68.4% after 72 h treatment with 50 µM of NAX012 and NAX014, respectively, compared with 44.2% of berberine. Real‐time PCR analyses showed that berberine, NAX012 and NAX014 compounds increased the expression of some cell‐cycle checkpoint molecules involved in cell senescence such as p53, p21WAF1, p16INK4a, and PAI‐1, already after 24 h of 50 µM treatments. Furthermore, berberine, NAX012 and NAX014, all reduced both HER‐2/neu expression and phosphorylation on tumor cells, the NAX014 compound showing the higher effectiveness. These results provide novel information on the mechanisms involved in the anticancer effects of berberine and demonstrate the greater effectiveness of NAX012 and NAX014 analogs in inducing apoptosis and cellular senescence in HER‐2/neu overexpressing tumor cell lines. © 2013 BioFactors, 39(6):672–679, 2013

Biomedicines

Antitumor Effect of Berberine Analogs in a Canine Mammary Tumor Cell Line and in Zebrafish Reporters via Wnt/β-Catenin and Hippo Pathways

Article

作者: Lombardi, Paolo ; Sacchetto, Roberta ; Geroni, Cristina ; Scarin, Giulia ; Sammarco, Alessandro ; Vettori, Andrea ; Ferro, Silvia ; Gelain, Maria Elena ; Zappulli, Valentina ; Beffagna, Giorgia ; Cavicchioli, Laura ; Bonsembiante, Federico

The heterogeneous nature of human breast cancer (HBC) can still lead to therapy inefficacy and high lethality, and new therapeutics as well as new spontaneous animal models are needed to benefit translational HBC research. Dogs are primarily investigated since they spontaneously develop tumors that share many features with human cancers. In recent years, different natural phytochemicals including berberine, a plant alkaloid, have been reported to have antiproliferative activity in vitro in human cancers and rodent animal models. In this study, we report the antiproliferative activity and mechanism of action of berberine, its active metabolite berberrubine, and eight analogs, on a canine mammary carcinoma cell line and in transgenic zebrafish models. We demonstrate both in vitro and in vivo the significant effects of specific analogs on cell viability via the induction of apoptosis, also identifying their role in inhibiting the Wnt/β-catenin pathway and activating the Hippo signals with a downstream reduction in CTGF expression. In particular, the berberine analogs NAX035 and NAX057 show the highest therapeutic efficacy, deserving further analyses to elucidate their mechanism of action more in detail, and in vivo studies on spontaneous neoplastic diseases are needed, aiming at improving veterinary treatments of cancer as well as translational cancer research.

100 项与 NAX-035 相关的药物交易

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研发状态

10 条进展最快的记录,

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